Stem Cell Therapy for Traumatic Brain Injury

Phase 2

Recruiting

Led By Charles S Cox, MD

Research Sponsored by Hope Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 (infusion 1), change from week 0 (infusion 1) at week 2 (infusion 2), change from week 0 (infusion 1) at week 4 (infusion 3), change from week 0 (infusion 1) at 6 months post-infusion, change from week 0 (infusion 1) at 1 year post-infusion

Summary

This trial tests if stem cells can help adults with brain injuries or lack of oxygen to the brain heal better.

Who is the study for?

This trial is for adults aged 18-55 with chronic traumatic brain injury, who can consent and communicate in English or Spanish. They should have documented neurological damage unlikely to improve with current treatments and a moderate disability level (GOS-E score >2 and ≤6). Excluded are those with intellectual deficits, psychiatric conditions, other serious health issues, pregnancy, participation in other drug/device trials, inability to undergo PET/DT-MRI tests or follow-up visits, recent infections, HIV+, certain allergies or diseases affecting organs like the liver and kidneys.

What is being tested?

The study is testing the safety and potential benefits of HB-adMSCs (stem cells derived from one's own fat tissue) given through an IV to improve brain structure and function after a traumatic brain injury. It compares this treatment against a saline solution placebo. The focus is on how well patients recover cognitively and structurally from their injuries.

What are the potential side effects?

While specific side effects aren't listed for HB-adMSCs since it's under investigation, common stem cell therapy risks include infection at injection site, immune system reactions causing fever or chills; however individual experiences may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, change from baseline at 6 months post-infusion, change from baseline at 1 year post-infusion for reporting.